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Is Levocetirizine Less Sedating Than Cetirizine?

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Douglas Tzanetos, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00826943
First received: January 20, 2009
Last updated: February 19, 2014
Last verified: February 2014
  Purpose

The purpose of this study is to determine whether cetirizine (zyrtec), levocetirizine (xyzal), and placebo differ in the degree of sedation they produce and their relief of allergy symptoms.


Condition Intervention Phase
Allergic Rhinitis
Drug: Cetirizine
Drug: Levocetirizine
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Is Levocetirizine Less Sedating Than Cetirizine? A Randomized, Double-blind, Placebo Controlled Trial.

Resource links provided by NLM:


Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • Modified Epworth Sleepiness Scale [ Time Frame: 36 days of the study ] [ Designated as safety issue: No ]

    Epworth Sleepiness Scale ratings (0 to 24); higher scores = increased sedation. This was measured over the 36 days of the study (at the end of each washout period and each intervention period); measured on days 5, 12, 17, 24, 29, and 36.

    This was mean data for all interventions.


  • Likert Score Rating Global Sedation [ Time Frame: duration of study (36 days) ] [ Designated as safety issue: No ]

    Likert score range 1 to 9 (no sedation to extreme sedation). Highers scores indicate increased sedation. This was measured on days days 5, 12, 17, 24, 29, and 36 of the study.

    This was mean data for all interventions.



Secondary Outcome Measures:
  • Total Four Symptom Scores (Allergy Symptoms) [ Time Frame: same as primary outcome measure (obtain on days 5, 12, 17, 24, 29, and 36) ] [ Designated as safety issue: No ]

    Total Four Symptom Scores (TFSS) ranging 0 to 12. Increased scores indicate increased symptoms. This was measured on days 5, 12, 17, 24, 29, and 36 of the study. The mean TFSS for patients receiving placebo, cetirizine, and levocetirizine was then calculated.

    This was mean data for all interventions.



Enrollment: 30
Study Start Date: January 2009
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Levocetirzine
5 mg daily x 7 days (note = cross over = all participants receive active comparators and placebo)
Drug: Levocetirizine
5 mg tab daily x 7 days
Active Comparator: cetirizine
10 mg daily x 7 days. Note = crossover study, so all participants recieve all active comparators and placebo.
Drug: Cetirizine
Cetirizine 10 mg tab daily x 7 days
Placebo Comparator: placebo
one tablet daily x 7 days; note that this is a crossover study so all participants receive all active comparators and placebo
Drug: Placebo
Placebo tablet daily x 7 days

Detailed Description:

Levocetirizine, the R-enantiomer of cetirizine, has been found to be less sedating relative to placebo than was cetirizine in separate trials. We plan to examine whether patients who did not tolerate cetirizine due to sedation are able to tolerate levocetirizine. This study will utilize a randomized, double-blind, placebo controlled trial comparing levocetirizine, cetirizine, and placebo in regards to sedation and allergy symptom scores. Each patient will receive levocetirizine, cetirizine, and placebo in randomized order and thus serve as their own control.

  Eligibility

Ages Eligible for Study:   18 Years to 77 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients 18 years of age or older
  • patients with perennial allergic rhinitis sensitized (positive RAST within the last 3 years or wheal greater than or equal to 3 mm within the last 3 years) to either:

    • dust mite
    • cat (if they own an indoor cat)
    • dog (if they own an indoor dog)
  • will allow for sensitization to tree, grass, or weed pollen, cockroach, or mold
  • history of reported sedation/somnolence when taking cetirizine
  • patient must have taken cetirizine for at least 1 week prior to discontinuing it
  • patients must have either tolerated levocetirizine in the past or have never tried levocetirizine.

Exclusion Criteria:

  • chronic urticaria requiring ongoing antihistamine or steroid treatment
  • atopic dermatitis requiring ongoing antihistamine or steroid treatment
  • URI or sinus infection during the 2 weeks preceding the beginning of the study
  • vasomotor (non-allergic) or irritant rhinitis
  • afrin use
  • elderly or over 77 years of age (could affect creatinine clearance) or chronic renal insufficiency
  • patients who have not tolerated levocetirizine in the past due to sedation.
  • taking other prescription or over the counter antihistamines and unwilling to stop them during the study
  • the presence of a sleep disorder such as sleep apnea or narcolepsy
  • the use of as needed sleeping aid medication
  • the presence of other chronic medical conditions which in the opinion of the investigator would prevent the subject from being able to participate effectively
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00826943

Locations
United States, Tennessee
Vanderbilt University Asthma, Sinus, and Allergy Clinic
Nashville, Tennessee, United States, 37203
Sponsors and Collaborators
Vanderbilt University
Investigators
Principal Investigator: Douglas B Tzanetos, M.D. Vanderbilt University
Study Chair: John M Fahrenholz, M.D. Vanderbilt University
  More Information

Publications:
Responsible Party: Douglas Tzanetos, Fellow, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00826943     History of Changes
Other Study ID Numbers: 080829
Study First Received: January 20, 2009
Results First Received: June 25, 2009
Last Updated: February 19, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Vanderbilt University:
Allergic Rhinitis

Additional relevant MeSH terms:
Rhinitis
Rhinitis, Allergic, Perennial
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Nose Diseases
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Respiratory Tract Diseases
Respiratory Tract Infections
Cetirizine
Levocetirizine
Anti-Allergic Agents
Histamine Agents
Histamine Antagonists
Histamine H1 Antagonists
Histamine H1 Antagonists, Non-Sedating
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 23, 2014